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Clinical Trial Manager

2 months ago


Montreal, Quebec, Canada Bristol Myers Squibb Full time
Job Summary

Bristol Myers Squibb is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for overseeing the execution of clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to achieve project goals.

Key Responsibilities
  • Coordinate country-level cross-functional teams and act as the main point of contact for a Country with the protocol manager and other global study team members.
  • Coordinate with other internal roles in country and site feasibility process, including proposal and validation of country study targets.
  • Develop country-level patient recruitment strategy & risk mitigation. Coordinate and ensure country-level study enrolment targets and timelines are met.
  • Lead problem-solving and resolution efforts, including management of risk, contingencies, issue resolution, and escalation to the appropriate stakeholder/s.
  • Assess and set up vendors during study start-up period (locally).
  • Investigator Meeting participation and preparation.
  • Ensure data entered in Clinical Trial Management Systems is current and complete, and access to eDC and vendor systems is available for the Country and clinical trial site personnel.
  • Validate study-related materials (i.e., protocol, ICF, patient material).
  • Responsible for preparing country-specific documents (e.g., global country-specific amendment).
  • Prepare materials for Site Initiation Visits.
  • Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
  • Reviews Site Monitoring visit reports, takes action within the timelines specified, and escalates issues and ensures appropriate documentation of issues.
  • Coordinate database locks and query follow-up. Ensure timelines are met.
  • Ensure inspection readiness of assigned trials within Country. Provide support to Health Authority inspection and pre-inspection activities.
  • Coordinates, develops, and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation, and completion.
  • Lead study team meetings locally.
  • Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable).
  • Management of Site relationships (includes CRO-related issues).
  • May support or conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs), as needed.
  • May support or perform site closure activities, including post-close out, as needed.
  • May act as point of contact for Sites.
  • May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees, and other relevant instances.
Senior Level Expectations
  • Engage with Global Trial Manager, line management, and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally.
  • Serve as a key resource for colleagues, by providing guidance, leading training, and mentoring to other team members through a mentoring process using informal and/or formal presentations.
  • May be assigned as a Lead CTM for a study locally and as determined by leadership.
Qualifications and Experience
  • Bachelor's degree required, preferably within life sciences or equivalent.
  • Clinical Trial Manager: Minimum of 4 years' industry-related experience.
  • Senior Clinical Trial Manager: At least 6 years of industry-related experience.
  • Experience in leading or participating as an active member of cross-functional teams, task forces, or local and global initiatives.
  • Thorough understanding of GCP, ICH Guidelines, and Country regulatory environment.
  • In-depth knowledge and understanding of clinical research processes, regulations, and methodology.
  • Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management.
  • Demonstrated organizational and planning skills and independent decision-making ability.
  • Strong organization and time management skills and ability to effectively manage multiple competing priorities.
  • Ability of critical thinking and risk analysis.
  • Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels.
  • Skilled in the use of technology.
  • Good verbal and written communication skills (both in English and French).
  • Suite Microsoft.
  • System of Clinical Trial Management (CTMS).
  • Electronic Data Capture (eDC) systems.
  • Electronic Trial Master File (eTMF) systems.